Comparison of the Effects of Two Different Wound Dressing on the Pressure Injury Patients in Long-term Care Institutions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed
研究概览
简要总结
Wound infection and bleeding is a risk factor for pressure injury. Calcium alginate silver dressing (CASD) has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in pressure injury(PI) patients in long-term care institutions, especially with respect to Taiwan population, is sparse. This study was to evaluate the effect of CASD and conventional wound dressings on the PI patients in long-term care institutions.
详细描述
Background: Wound infection and bleeding is a risk factor for pressure injury. Calcium alginate silver dressing (CASD) has been shown to be beneficial in a variety of wounds. However, evidence of its benefit in PI patients in long-term care institutions, especially with respect to Taiwan population, is sparse.
Objective
To evaluate the effect of CASD and conventional wound dressings on the PI patients in long-term care institutions. The study hypothesis that when using the CASD will improving wound bed status more than conventional dressing change.
Design: Prospective, randomized trial Setting: Multiple center long-term care institutions in Taiwan. Methods: In this clinical trial, 200 PI patients will randomly assigned to treatment with either calcium alginate silver dressing or conventional wound dressings for up to 14 days or to the point of full reepithelialization of the wound. The length and depth of the studied wounds were recorded once a week. The instruments will using the PI measurement tool measured on day0, day7 and day14.The collected data were analyzed by descriptive and inferential statistical methods . The Mann-Whitney test was applied to compare primary endpoint between groups. Differences in secondary endpoint were also compared.
Expected results: PI is an indicator of care quality in long-term care institutions. However, as the population ages, PI are prone to infection and bleeding problems, causing patients to have potential health problems such as sepsis and hemoglobin reduction. The results of this study will provide evidence-based care for wound dressing in long-term care institutions, thereby improving patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Before the subjects were assigned, neither the participants, nurses nor the researchers knew whether the subjects were in the experimental group or the control group. When the patients met the inclusion criteria, the research assistant informed the clinical nurses of the results of the case assignment(experimental group or control group).
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20-90 years old
- •Stage II or stage III pressure injury
- •Pressure injury wound size: length, width and depth are less than 10*10*2 cm
- •The patient or family agree to be willing to participate in and cooperate with the interventional treatment of this study
排除标准
- •The wound has a underming wound or a tunnel wound
- •Black crust on the wound bed
- •Participant's with unstable vital signs
- •Those who have used silver dressings or silver hydrofiber dressings in the past 30 days
- •The patient has any other related disease symptoms that may interfere with the safety and efficacy of the study results
- •Long-term care institutions are protected resettlement or homeless people without legal representatives
结局指标
主要结局
Change bacterial colony count in wound bed Bacterial colony count in wound bed Bacterial colony count in wound bed
时间窗: Change from baseline bacterial colony count in wound bed at 14 days
Take bacteria from the wound bed for wound culture
Change high sensitivity C- reactive protein(hsCRP)
时间窗: Change from hsCRP at 14 day
Draw 2cc of blood for analysis of white blood cell count
Change white blood cell count
时间窗: Change from white blood cell count at 14 day
Draw 2cc of blood for analysis of white blood cell count
次要结局
- Change Wound Bed Condition Assessment Scale(Change from wound bed condition assessment at 14 day)
研究者
Shu-Fen Lo
Associate Professor
Tzu Chi University